PMA P130021S179

Device: Evolut PRO, PRO+, FX, FX+
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S179
Product code: NPT
Decision date: 2026-02-12
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs

Current openFDA PMA Record#

Device: Evolut PRO, PRO+, FX, FX+
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S179
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-02-12
Decision code: APPR
Date received: 2025-09-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs